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| Title | A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of lenalidomide (Revlimid®) as maintenance therapy for high-risk patients with chronic lymphocytic leukemia following first-line therapy |
|---|---|
| Protocol IDs | EUDRACT-2011-004698-98 NCT01556776 |
| Recruitment Status | prematurely terminated due to slow recruitment rate; trial in follow up |
| Contact | Medical Management: Dr. Anna Fink Dr. Anna Fink Aline Zey Jan-Erik Mittler Sabine Frohs |
| Contact for scientific queries | Dr. Anna Fink Dr. Anna Fink |
| Design | Prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group phase III study |
| Primary Endpoint(s) | Progression-Free Survival (PFS) based on independent review committee |
| Secondary Endpoints | - Progression free survival (PFS) – assessed by the investigator - Overall survival (OS) - Safety (AEs, premature terminations of the trial) - Assessment of Minimal Residual Disease (MRD) - Quality of life (EORTC QLQ C30 and EQ-5D) - Time until next treatment - Event free survival (EFS) - Treatment free interval after secondary therapy |
| Study Population | B-CLL according to the IWCLL guidelines - Must have been treated with one of the first line induction therapies: fludarabine/cyclophosphamide/rituximab, or bendamustine/rituximab or fludarabine/rituximab or fludarabine/cyclophosphamide,(in case of hypersensitivity reactions to Rituximab). - Must have achieved a response of at least PR (according to the IWCLL guidelines) following completion (minimum 4 cycles) of first-line induction therapy prior to randomization (documentation of response status must be available). and have either: a. MRD levels in the peripheral blood at final restaging of ≥ 10-2 or b. MRD levels in the peripheral blood ≥10-4 - <10-2 combined with at least one of the following factors: • an unmutated IGHV-status • 17p-deletion or • TP53 mutation Must have completed last cycle of at least 4 cycles of first-line induction no less than 8 weeks (56 days) and no greater than 20 weeks (140 days) prior to randomization ECOG ≤ 2 CIRS-Score ≤ 6 and no single score of ≥ 4 for an organ system Age ≥ 18 years Exclusion criteria: Autologous or allogeneic bone marrow transplant as first line therapy, Prior therapy with lenalidomide, Richter’s Syndrome |
| Treatment | Daily administration of placebo or lenalidomide in a 28-day cycle until disease progression, unacceptable toxicity
or voluntary treatment withdrawal, whichever occurs first. Dose escalation from 5 mg up to a maximal daily dose of 25 mg if well tolerated and MRD levels are ≥ 10-4. |
| Enrollment | 89 patients |
| Time schedule | Recruitment period: 20 July 2012 - 24 January 2016 Activation of Amendment 1: 12 February 2014 Activation of Amendment 2: 11 August 2014 Activation of Amendment 3: 26 January 2016 Activation of Amendment 4: 04 July 2016 Activation of Amendment 5: 20 December 2016 Estimated end of study: 03/2021 |
| Protocol Version | Protocol (V. 2.1 / 04 June 2012) Amendment 1 (V. 3.0 / 05 July 2013) Amendment 3 (V. 4.0 / 20 October 2015) Amendment 5 (V. 5.0 / 11 October 2016) |
| Sponsor | University of Cologne |
| Principal Investigator | Prof. Dr. Barbara Eichhorst, Internal Medicine I, University Hospital of Cologne |
| Documents (publicly available) |
Synopsis (V. 5.0 / 11 October 2016) |
| Documents (password protected) |
Protocol and other documents see Download Center |
| Publications | Fink AM, Bahlo J, Robrecht S, Al-Sawaf O, Aldaoud A, Hebart H, Jentsch-Ullrich K, Dörfel S, Fischer K, Wendtner CM, Nösslinger T, Ghia P, Bosch F, Kater AP, Döhner H, Kneba M, Kreuzer KA, Tausch E, Stilgenbauer S, Ritgen M, Böttcher S, Eichhorst B, Hallek M Lenalidomide maintenance after first-line therapy for high-risk chronic lymphocytic leukaemia (CLLM1): final results from a randomised, double-blind, phase 3 study Lancet Haematol. 2017 Sep 12 pii: S2352-3026(17)30171-0. doi: 10.1016/S2352-3026(17)30171-0. [Epub ahead of print] |